CLS and Toronto General Hospital Resume Clinical Trial for Prostate Cancer as Company Receives Approval for Updated Sterilization Process by Health Canada
Lund, Sweden, 12 July, 2021 - Clinical Laserthermia Systems AB (publ) (CLS), developer of high precision, image-guided focal laser ablation systems, today announced it has received approval from Health Canada for its updated sterilization documentation as well as an acceptance for its new sterilization supplier, ROSE GmbH. This means that CLS and University Health Network, that includes Toronto General Hospital in Toronto, Canada, can now resume the clinical Phase II trial, led by Dr. Sangeet Ghai, regarding MRI-guided focal laser ablation of organ confined low-intermediate risk early prostate cancer.
In April of 2021, CLS issued a recall of its sterile, single-use instruments after receiving information from the company’s sterilization service provider regarding deficiencies in its sterilization processes. This resulted in a temporary pause in clinical trials using CLS’ products. The study at Toronto General Hospital with a total of 55 patients was paused after treating approximately 30 patients. With the recent approval from Health Canada, the trial activities can now proceed.
“CLS is very pleased to receive approval from Health Canada for our updated sterilization process. We are now back on track in our collaboration and this very important clinical trial. In the coming weeks, we expect to have the new sterilization process and supplier approved in all markets where we are active,” says Dan Mogren, Acting CEO of CLS.
About MRI-guided Focal Laser Ablation for Prostate Cancer: Men diagnosed with localized low-to-intermediate risk prostate cancer and with a significant life expectancy are usually offered the choice of two broad therapeutic options, either active treatment with surgery or irradiation with a high risk of side effects. Based on its high precision and minimally invasive treatment, MRI has increased opportunities in management of prostate cancer. Additionally, MR thermometry allows real time, peri-procedural monitoring to ensure precise targeting selective and accurate tumour ablation. Focal therapy (FT) for prostate cancer (PCa) reduces functional quality of life complications and provides promising oncological results. Magnetic resonance image (MRI)-guided Focal Laser Ablation (MRgFLA) potentially maximizes treatment precision. In this Phase II study, non-water cooled 1064nm diode laser fibers were used for ablation. This study aims to determine the oncologic and functional outcomes of MRgFLA in low-to-intermediate risk localized prostate cancer in the single-center series of patients treated with the 1064nm diode laser fibers.
The information was submitted by the contact person on 12 July 2021 at 1 PM CET.
Dan J. Mogren, Acting CEO Clinical Laserthermia Systems AB (publ)
Ph: +46 – (0)705 – 90 11 40
E-mail: dan.mogren@clinicallaser.com
Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG®|Thermal Therapy System, including Thermoguide Workstation and sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy, according to regulatory approvals in the EU and the US. The products are marketed for image-guided laser ablation and for treatment with imILT®, the Company's interstitial laser thermotherapy with potential immunostimulatory effects. CLS is headquartered in Lund and has subsidiaries in Germany, the US and Singapore. CLS is listed on the Nasdaq First North Growth Market under the symbol CLS B. The Certified Advisor (CA) is FNCA Sweden AB, Tel: +46 8 528 00 399. E-mail: info@fnca.se.
For more information about CLS, please visit the Company's website: www.clinicallaser.se
The TRANBERG®|Thermal Therapy System has not yet received market clearance for immune stimulating interstitial laser thermotherapy (imILT®) or its Thermoguide thermometry software by the Food and Drug Administration (FDA) in the United States of America (USA).